CHMP’s March Recommendations Include Dinutuximab, Nonacog Beta Pegol And Trumenba
The European Medicines Agency’s Committee for Medicinal Products for Human Use (CHMP) meets monthly to review applications for centralized EU marketing authorization. Here’s a summary of their March 2017 recommendations.
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Novo’s long-acting coagulation Factor IX showed polyethylene glycol (PEG) accumulation in the choroid plexus of animals, potentially raising a neurological safety issue when used in humans, FDA says ahead of Blood Products Advisory Committee review.
Pipeline Watch is a weekly snapshot of selected late-stage clinical trial events and approvals announced by pharmaceutical and biotech companies at medical and industry conferences, in financial and company presentations, and in company releases and statements.
Alexion/AstraZeneca has announced positive top-line results from the Phase III study of ALXN1840 in patients with the rare genetic disorder, Wilson disease, including in patients already on standard-of-care therapies. The compound is ahead of two candidate gene therapies from other companies at early-stage clinical development.